June 4, 2014

Stanton A. Glantz, PhD

FDA Should Prohibit Flavors in all Tobacco Products in the Current Rule Making

A group of scientists from UCSF and Stanford (Ganna Kostygina, PhD, Elizabeth Couch, RDH, MS, Margaret Walsh, Ed.D., Rachel Grana, MPH, PhD, Bonnie Halpern-Felsher, PhD, FSAHM,*Lauren K. Lempert, JD, MPH, Pamela M. Ling, MPH, MD) have submitted an extensive public comment to FDA on the issue of flavored tobacco products.
The full comment is 13 pages long and available as a PDF here.
Here is the first two paragrpahs oft he comment:
While fruit, candy and alcohol flavored cigarettes have been banned by the 2009 Family Smoking Prevention Tobacco Control Act (TCA)[i], other flavored tobacco products such as smokeless tobacco, cigars, hookah, and electronic cigarettes (e-cigarettes) continue to be sold. Similar to cigarettes, sales and promotion of flavored alternative tobacco products attract youth and new users to these products and encourage novices and youth to start using tobacco. In addition, use of flavorings contributes to dual use of cigarettes and other tobacco products among those who are trying to quit smoking cigarettes and those who do not distinguish between cigarettes and little cigar products. FDA recognizes in its proposed deeming that it has the authority under sections 906(d) and 907 of the Family Smoking Prevention Tobacco Control Act (TCA)[ii] to issue regulations requiring restrictions on the sale and distribution of tobacco products that would be appropriate for the protection of the public health, including adopting tobacco product standards that prohibit the use of flavors in all covered tobacco products; however, the FDA fails to take this essential step.[iii] FDA already has more than sufficient evidence (additional evidence overviewed below) demonstrating why flavors that attract youth to a lifetime of addiction to toxic tobacco products in various forms must be banned.  FDA should immediately under the current rulemaking establish a product standard prohibiting flavors in e-cigarettes, cigars, hookah, and all other covered tobacco products. 
Failing to prohibit all flavors of covered tobacco products would defeat the purpose of the law to reduce the population level public health impact of tobacco use, which inherently includes reducing all tobacco use among youth.  In addition, before manufacturers are allowed to market any kind of tobacco product with flavors, including newly deemed products, these companies must provide data to FDA demonstrating the safety of inhaling and ingesting flavor additives, and, most important, that the use of these flavors does not increase use of the products by youth and are appropriate for the protection of public health.

[i]Pub.L. 111-31, H.R. 1256 (June 22, 2009)

[ii] Pub.L. 111-31, H.R. 1256 (June 22, 2009)

[iii]79 FR 23142 at 23143, 23147, 23149

The comment tracking number is 1jy-8chl-vs81.

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